DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K073092
Device Name DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
Applicant
SPIRE BIOMEDICAL INC
one patriots park
bedford, 
MA 
01730

Applicant Contact raymond kelly
Correspondent
SPIRE BIOMEDICAL INC
one patriots park
bedford, 
MA 
01730

Correspodent Contact raymond kelly
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 11/01/2007
Decision Date 01/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No